南方医科大学学报

南方医科大学学报 ›› 2020, Vol. 40 ›› Issue (10): 1488-1492.doi: 10.12122/j.issn.1673-4254.2020.10.15

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医用臭氧油防治索拉非尼所致手足皮肤反应： 91例随机对照临床试验

陈晓薇, 江一越, 张 颖, 戴文聪, 樊 蓉, 翁 勰, 贺 鹏, 晏菲菲, 郭亚兵   

  • 出版日期:2020-10-20 发布日期:2020-10-20

Effect of ozone oil for prevention and treatment of sorafenib-induced hand-foot skin reactions: a randomized controlled trial

  • Online:2020-10-20 Published:2020-10-20

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摘要： 目的 对比医用臭氧油和尿素软膏在预防和治疗索拉非尼治疗肝细胞癌（HCC）所导致手足皮肤反应（HFSR）的效果。方法 于2018年4月~2020年1月共入组99例依据美国国家综合癌症网（NCCN）指南诊断标准确诊为晚期原发性肝癌并且首次接受索拉非尼治疗的患者，按照数字随机方法分为试验组和对照组，其中试验组（医用臭氧油组）49例，对照组（尿素软膏组）50例。在开始服用索拉非尼治疗时，试验组和对照组患者分别给予医用臭氧油和10%尿素软膏外涂，均匀涂抹手掌和足底皮肤，包括指缝、关节处。试验组采用医用臭氧油涂抹手足，1 mL/次，3次/d；对照组采用10%尿素软膏涂抹手足，2 g/次，3次/d。两组皆护理干预12周，随访14周，每2周观察HFSR发生情况。结果 在排除8例因依从性不佳或方案违背的患者后，共计91例被纳入分析，其中试验组44例，对照组47例。在随访过程中，试验组累积16例（36.4%）发生HFSR，显著低于对照组27例（57.4%），（P<0.05）；2/3级HFSR占15.9%（7/44），低于对照组27.7%（13/47）。结论 相较于尿素软膏组，医用臭氧油可显著降低HCC患者使用索拉非尼治疗时HFSR发生率，减轻HFSR严重程度，从而改善索拉非尼治疗患者的生活质量，提高患者的治疗依从性。

关键词: 护理干预, 医用臭氧油, 索拉非尼, 手足皮肤反应, 晚期肝细胞癌

Abstract: Objective To compare the effects of medical ozone oil and urea ointment for prevention and treatment of hand-foot skin reaction (HFSR) caused by sorafenib in patients with hepatocellular carcinoma (HCC). Methods A total of 99 patients diagnosed with advanced HCC according to National Comprehensive Cancer Network (NCCN) who were scheduled to receive sorafenib treatment for the first time were enrolled in this study between April, 2018 and January, 2020. The patients were randomized into medical ozone oil group (n=49) and urea ointment group (control group, n=49) for treatment with local application of 1 mL medical ozone oil (experimental group) and 10% urea ointment (2 g) on the palm and plantar skin
(including the fingers and joints) for 12 weeks (3 times per day) starting at the beginning of sorafenib treatment, respectively.
The patients were observed for occurrence of HFSR every 2 weeks for 14 weeks. Results Eight patients were excluded for poor
compliance or protocol violations, leaving a total of 91 patients for analysis, including 44 in medical ozone oil group and 47 in
urea ointment group. Sixteen (36.4%) of patients in ozone oil group developed HFSR, a rate significantly lower than that in
urea ointment group (57.4%; P<0.05). The incidence of grade 2/3 HFSR was also lower in ozone oil group than in urea ointment
group (15.9% [7/44] vs 27.7 [13/47]). Conclusion Medical ozone oil can significantly reduce the incidence and severity of HFSR
to improve the quality of life of HCC patients receiving sorafenib treatment.

Key words: nursing intervention, ozone oil, sorafenib, hand-foot skin reaction, advanced hepatocellular carcinoma